Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00458354
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2007-03-29
Brief Title:
Use of Spinal Sealant System During Spinal Surgery
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Prospective Multi-Center Randomized Controlled Study to Compare the Spinal Sealant System as an Adjunct to Sutured Dural Repair With Standard of Care Methods During Spinal Surgery
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods control to obtain watertight dural closure intraoperatively in patients undergoing spinal surgery
2 To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods control to obtain watertight dural closure in patients undergoing spinal surgery up to 90 days post-procedure
2 To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods control to obtain watertight dural closure in patients undergoing spinal surgery up to 90 days post-procedure
Detailed Description:
The CSF provides a liquid cushion for the brain and spinal cord The dura holds in the CSF In order to do spinal surgery the doctor will cut an opening in the dura At the end of surgery the dura must be sealed in order to keep the CSF from leaking out The doctor will close the dura with stitches and also a piece of tissue taken from another place on your body to help close the opening Other standard sealant methods have included the use of Oxicel Gelfoam or fibrin glue but these methods were not designed for closing the dura
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in this study Your doctor will see you within 30 days before your operation At this visit your medical history will be recorded and you will be asked questions about any other operations you have had in the past You will have a complete physical exam including measurement of vital signs blood pressure heart rate temperature and breathing rate height and weight You will have a sample of your blood about 2 tablespoons collected for kidney and liver function tests to make sure they are functioning properly You will also be asked to fill out 2 questionnaires about your health daily activities and back pain The questionnaires will take about 20 to 30 minutes to complete Women who are able to have children must have a negative blood pregnancy test
If you are found to be eligible to take part in this study you will be randomly assigned as in the toss of a coin to one of 2 treatment groups Participants in one group will receive the Spinal Sealant You have a 2 out of 3 chance of being randomly assigned to the spinal sealant group Participants in the other group will receive other standard methods such as the closing of the dura with stitches However you will not know which one of the two treatments you receive Also if needed a piece of your muscle fat or other soft tissue may be taken from another place on your body to help seal the opening Doctors may also use Oxicel Gelfoam or fibrin glue to help with the sealing of the dura
After your already scheduled spinal surgery your doctor will try to close the opening in the dura which may be done with stitches alone or if needed stitches and a piece of your muscle fat or other soft tissue taken from another place on your body After this try if there is still some CSF leaking from the dura you will be assigned to one of the 2 groups for treatment If you do not have a CSF leak that needs treatment you will not be able to take part in this study and you will not have to come back for any study visits
Participants assigned to the first group will receive treatment with the Spinal Sealant which will be sprayed over their stitches to close the opening in their dura The Spinal Sealant is made of 2 plastic-type liquids When mixed together a gel is formed that is mostly made up of water The gel looks and feels sort of like a soft contact lens After the doctor tries to seal the opening in the dura the Spinal Sealant is then sprayed over the stitches It acts like a thin stretchy covering to help stop the CSF from leaking out through the stitches until the area has properly healed on its own It is blue-colored so that the doctor can see where it has been sprayed Within 1 to 2 months the gel is naturally broken down by the body and is removed through the urine
Participants assigned to the second group will be treated with the doctors choice of other standard treatments to close the opening in their dura You will not know which group you were assigned to until after the end of your study participation about 90 days
While you are still in the hospital within 7 days after your operation you will have a physical exam and your doctor will do a clinical test to check for any CSF leaks Also you will have a sample of your blood about 2 tablespoons drawn for kidney and liver function tests
For follow-up you will be seen by your doctor at about 30 days and again at about 90 days after your operation It will be very important for you to return to see your doctor at your scheduled follow-up visits even if you are feeling fine At the follow-up visits your doctor will perform a physical exam and check to see how your dura wound is healing and if there is any CSF leakage You will have a sample of your blood about 2 tablespoons collected for kidney and liver function tests You will also be asked to fill out 2 questionnaires about your health daily activities and back pain The questionnaires will take about 20 to 30 minutes to finish
Your participation in this study will be over after your 90-day follow-up visit
THIS IS AN INVESTIGATIONAL STUDY The Spinal Sealant has been authorized by the FDA for use in research only
About 158 patients will take part in this multicenter study Between 15 to 20 participants will be enrolled at M D Anderson
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in this study Your doctor will see you within 30 days before your operation At this visit your medical history will be recorded and you will be asked questions about any other operations you have had in the past You will have a complete physical exam including measurement of vital signs blood pressure heart rate temperature and breathing rate height and weight You will have a sample of your blood about 2 tablespoons collected for kidney and liver function tests to make sure they are functioning properly You will also be asked to fill out 2 questionnaires about your health daily activities and back pain The questionnaires will take about 20 to 30 minutes to complete Women who are able to have children must have a negative blood pregnancy test
If you are found to be eligible to take part in this study you will be randomly assigned as in the toss of a coin to one of 2 treatment groups Participants in one group will receive the Spinal Sealant You have a 2 out of 3 chance of being randomly assigned to the spinal sealant group Participants in the other group will receive other standard methods such as the closing of the dura with stitches However you will not know which one of the two treatments you receive Also if needed a piece of your muscle fat or other soft tissue may be taken from another place on your body to help seal the opening Doctors may also use Oxicel Gelfoam or fibrin glue to help with the sealing of the dura
After your already scheduled spinal surgery your doctor will try to close the opening in the dura which may be done with stitches alone or if needed stitches and a piece of your muscle fat or other soft tissue taken from another place on your body After this try if there is still some CSF leaking from the dura you will be assigned to one of the 2 groups for treatment If you do not have a CSF leak that needs treatment you will not be able to take part in this study and you will not have to come back for any study visits
Participants assigned to the first group will receive treatment with the Spinal Sealant which will be sprayed over their stitches to close the opening in their dura The Spinal Sealant is made of 2 plastic-type liquids When mixed together a gel is formed that is mostly made up of water The gel looks and feels sort of like a soft contact lens After the doctor tries to seal the opening in the dura the Spinal Sealant is then sprayed over the stitches It acts like a thin stretchy covering to help stop the CSF from leaking out through the stitches until the area has properly healed on its own It is blue-colored so that the doctor can see where it has been sprayed Within 1 to 2 months the gel is naturally broken down by the body and is removed through the urine
Participants assigned to the second group will be treated with the doctors choice of other standard treatments to close the opening in their dura You will not know which group you were assigned to until after the end of your study participation about 90 days
While you are still in the hospital within 7 days after your operation you will have a physical exam and your doctor will do a clinical test to check for any CSF leaks Also you will have a sample of your blood about 2 tablespoons drawn for kidney and liver function tests
For follow-up you will be seen by your doctor at about 30 days and again at about 90 days after your operation It will be very important for you to return to see your doctor at your scheduled follow-up visits even if you are feeling fine At the follow-up visits your doctor will perform a physical exam and check to see how your dura wound is healing and if there is any CSF leakage You will have a sample of your blood about 2 tablespoons collected for kidney and liver function tests You will also be asked to fill out 2 questionnaires about your health daily activities and back pain The questionnaires will take about 20 to 30 minutes to finish
Your participation in this study will be over after your 90-day follow-up visit
THIS IS AN INVESTIGATIONAL STUDY The Spinal Sealant has been authorized by the FDA for use in research only
About 158 patients will take part in this multicenter study Between 15 to 20 participants will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None